Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Camrelizumab + Nimotuzumab + Carboplatin + Albumin Paclitaxel + radiotherapy + surgery
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form; 2. 18-75 years old, no gender limit; 3. Cytology or histology is confirmed as esophageal squamous cell carcinoma; 4. Local treatments for primary esophageal tumors have not been performed in the past, including surgical treatment and radiotherapy; 5. Clinical staging: cT2-4a, N0-3, M0 (AJCC/UICC staging of esophageal cancer [eighth edition]); 6. The primary tumor can be evaluated; 7. No distant organ metastasis; 8. PS score 0-1 points; 9. Estimated survival period >= 6 months; 10. The main organs are functioning normally, meet the following standards: (1) Routine blood examination: HBG >= 90 g/L; ANC >= 1.5 x 10^9/L; PLT >= 80 x 10^9/L; (2) Biochemical inspection: ALB >= 30 g/L; ALT and AST = 60 ml/min; 11. Pulmonary function: FEV1/FVC >= 70%, FEV1 >= 50% normal value, the percentage of DLCO (lung diffusion function) measured value and predicted value > 80%; 12. Women of childbearing age must be pregnant within 7 days before starting treatment and the result is negative; 13. All patients in the group should take adequate contraceptive measures during the entire treatment period and 4 weeks after the end; 14. No serious hematopoietic function, abnormal heart function and immune deficiency; 15. There is no perforation of the esophagus and active bleeding of the esophagus, no invasion of the trachea and large blood vessels in the chest cavity.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, Nephritis, hyperthyroidism; patients suffering from vitiligo; asthma has been completely relieved in childhood, and no intervention is required after adults can be included; patients who require bronchodilators for medical intervention can not be included); 2. The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before enrollment; 3. Have received EGFR monoclonal antibody or EGFR tyrosine kinase inhibitor treatment in the past; 4. Patients with any severe and/uncontrolled diseases, including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); patients with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval >= 480 ms), and grade I cardiac insufficiency; (2) Active or uncontrolled serious infection; (3) Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA >= 104 copy number/ml or 2000 IU/ml) or hepatitis C (hepatitis C antibody is positive and HCV-RNA is higher than the detection limit of the analysis method); 5. Patients whose imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; 6. Pregnant or lactating women; 7. Patients suffering from other malignant tumors within 5 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 8. Patients with a history of psychotropic drug abuse and unable to quit or patients with mental disorders; 9. Patients who have participated in other drug clinical trials within four weeks; 10. According to the judgment of the investigator, there are patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 11. The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate;Pathological main remission rate; | — |
Countries
China
Contacts
Public ContactQian Dong
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Outcome results
None listed